The diagnosis of the above disorders is often difficult, due to overlapping symptoms, and therefore usually supported by measuring their associated auto-antibodies.

In the EULISA ANA Profile 8 IgG, eight antigens specifically recognised by these antibodies are immobilised, line by line, on the solid phase (reference: Instructions for use):

Antigen

Source

Disease

Autoantibody prevalence

dsDNA

Plasmid

SLE

60 - 90 %

RNP (proteins A, C, 68kDa)

Recombinant

MCTD

95 %

SLE

30 - 40 %

PM

14 %

SS

4 %

Sm (proteins B, B, D)

Bovine thymus

SLE

12 - 39 %

MCTD

7 %

SS-A/Ro (60kDa-protein)

Bovine thymus

SS

60 - 100 %

SLE

45 - 50 %

MCTD

15 - 30 %

PSS

5 - 7 %

PM

5 - 7 %

SS-B/La

Recombinant

SS

30 - 90 %

SLE

15 - 30 %

MCTD

5 - 15 %

Scl-70 (DNA-topoisomerase 1)

Recombinant

PSS

20 - 76 %

CENP-B (centromere protein B)

Recombinant

CREST

40 - 80 %

Jo-1 (Histidyl-tRNA-synthetase)

Recombinant

PM

20 - 40 %

Technical information

The test is designed for the individual, qualitative determination of IgG autoantibodies in human serum, directed against one or several of the above antigens. The test is fast (incubation time 30-30-30 minutes) and flexible (8-well strips, 1-12 analyses, ready-to-use reagents). A negative and a positive control are used to check assay performance. The positive control also serves as calibrator for assay evaluation.

Kit components and storage of reagents

Contents of the kit

One microwell plate, coated line by line with eight individual autoantigens and hermetically packed in a foil laminate pouch together with a desiccant bag.